FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

5,198 results for "health"
3145–3168 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 20, 2002
ENRAF-NONIUS ENDOMED 182 SYSTEM
K003744 · GZJ
Henley Healthcare, Inc.
Neurology · 443d
Cleared Feb 12, 2002
TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601
K020083 · HRX
Tuta Healthcare Pty Limited
Orthopedic · 33d
Cleared Feb 11, 2002
MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
K014301 · CAW
Merits Health Products Co., Ltd.
Anesthesiology · 42d
Cleared Feb 04, 2002
ADVANCED AIR PURIFICATION SYSTEM
K012549 · FRF
Healthway Products, Inc.
General Hospital · 181d
Cleared Jan 25, 2002
COSMO TENS PF-990 MINI DIGITAL WIRELESS PATCH
K013507 · GZJ
Cosmo Health, Inc.
Neurology · 95d
Cleared Jan 22, 2002
POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G)
K014134 · FMC
Supergrade Healthcare Products Sdn. Bhd.
General Hospital · 36d
Cleared Jan 17, 2002
GLOBAL HEALTHCARE VAGINAL SPECULUM
K013835 · HIB
Dynascend Consulting Int'L, LLC
Obstetrics & Gynecology · 59d
Cleared Jan 17, 2002
HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009
K012037 · CAW
Airsep Corp.
Anesthesiology · 202d
Cleared Jan 16, 2002
HL168E
K014122 · DXN
Health & Life Co., Ltd.
Cardiovascular · 30d
Cleared Jan 10, 2002
BODYGEM, MODEL HB211
K010577 · BZL
Healthetech, Inc.
Anesthesiology · 317d
Cleared Jan 08, 2002
L-25 ABSORBABLE SURIGCAL SUTURE
K013671 · GAM
United States Surgical, A Division of...
General & Plastic Surgery · 63d
Cleared Dec 31, 2001
MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE
K013556 · FOZ
Tyco Healthcare
General Hospital · 67d
Cleared Dec 19, 2001
AUTO SUTURE SURGICAL STAPLES
K013860 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 28d
Cleared Dec 17, 2001
DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TESTED FOR USE...
K013302 · KGO
Allegiance Healthcare Corp.
General Hospital · 75d
Cleared Dec 13, 2001
NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84)...
K013992 · CEW
Nichols Institute Diagnostics
Chemistry · 9d
Cleared Dec 11, 2001
SURGICAL DYNAMICS MENISCAL STAPLE
K013890 · HWC
United States Surgical, A Division of...
Orthopedic · 18d
Cleared Dec 11, 2001
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 5
K013788 · INI
Merits Health Products Co., Ltd.
Physical Medicine · 27d
Cleared Dec 06, 2001
MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123
K013027 · BTI
Respironics Healthscan, Inc.
Anesthesiology · 87d
Cleared Dec 05, 2001
HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302,...
K012988 · FKX
Baxter Healthcare Corp
Gastroenterology & Urology · 90d
Cleared Dec 03, 2001
XPLAN 2.2 WITH THE BODY SYSTEM
K013661 · MUJ
Radionics, A Division of Tyco...
Radiology · 27d
Cleared Nov 29, 2001
KP + LFM
K013489 · BZH
Pds Healthcare Products, Inc.
Anesthesiology · 38d
Cleared Nov 29, 2001
HPI SENSI GRIP STERILE POWDERED LATEX SURGICAL GLOVE,WITH LABELED PROTEIN...
K013324 · KGO
Tillotson Healthcare Corp.
General Hospital · 55d
Cleared Nov 29, 2001
MOTEX NITRILE EXAMINATION GLOVES POWDER-FREE
K013261 · LZA
Shanghai Motex Healthcare Co., Ltd.
General Hospital · 59d
Cleared Nov 19, 2001
RECORDING AND STIMULATING ELECTRODE
K012850 · GZL
Radionics, A Division of Tyco...
Neurology · 87d